News

FDA has approved fluocinolone acetonide intravitreal implant (Iluvien, Alimera) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.

Adding pertuzumab (Perjeta, Roche) to trastuzumab (Herceptin, Genentech) and docetaxel chemotherapy extended the lives (overall survival; OS) of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy (median OS: 56.5 vs. 40.8 months), according to data presented at the European Society for Medical Oncology 2014 congress in Madrid, Spain.

FDA approved methylnaltrexone bromide (Relistor, Salix Pharmaceuticals and Progenics Pharmaceuticals) subcutaneous injection, 12 mg/0.6 mL, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain.

Today’s launch of the Open Payments website has trade and physician associations worried about the accuracy and presentation of its data.

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.

FDA has approved updated label changes for the smoking cessation drug, varenicline (Chantix, Pfizer).

At least five state health insurance exchanges are making major changes in their websites for the 2015 open enrollment period

All-encompassing change to the U.S.’s end-of-life care system is urgently needed.

Concerns about cost and ROI are widespread

CMS recently issued quality and financial performance results showing that Medicare ACOs have improved patient care and produced hundreds of millions of dollars in savings for the program. But when the numbers are broken down, only half of the ACOs in the two programs saw any return on investment.

The website was breached on July 8 but no consumer information was taken

FDA has approved Otezla (apremilast, Celgene) for treating moderate-to-severe plaque psoriasis in patients who are considered candidates for systemic therapy or phototherapy.

Underpinning FDA clearance were data gathered from a study of more than 1650 patients with a variety of medical conditions and medications who were being treated in different hospital departments like cardiac, emergency intensive care, and surgical departments. In all of the various types of patients being tested, study results found agreement in blood glucose results versus a comparator laboratory glucose analyzer.

77 new issuers will offer marketplace coverage.

In an increasing effort to continue to play a complementary role with primary care practices in providing care to patients, CVS Health has worked to deplete existing cigarette inventory at CVS/pharmacy stores without receiving new shipments.

lthough the growing public outcry surrounding antibiotic resistance has only recently propelled sepsis back into the international spotlight, in reality, the sepsis marketplace has been one of high unmet medical need for decades. The condition, which currently lacks specific therapies beyond antimicrobials and basic supportive care, has quietly evolved into one of the most urgent medical issues facing our healthcare system today

Oral vancomycin (Vancocin) prophylaxis may be effective for the prevention of recurrent Clostridium difficile infection with minimal risk to the patient, according to a poster presentation at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

FDA has approved Trulicity (dulaglutide, Eli Lilly) to treat type 2 diabetes mellitus.

Post-hoc analysis found that, despite continued titration with insulin glargine, more diabetes patients achieved sustained glycemic control with exenatide once-weekly, according to data presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.

Four-year data from a phase 3 study examined the durability of glycemic response with dapagliflozin as add-on therapy to metformin vs. glipizide in patients with type 2 diabetes inadequately controlled with metformin alone. The data was presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.

Insulin degludec/insulin aspart (Ryzodeg, Novo Nordisk) administered twice daily, provides successful glycemic control with fewer injections than a basal-bolus regimen, according to data presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.

As many as 11.4 million antibiotic prescriptions written each year for children and teens may be unnecessary, according to a study in the October 2014 issue of Pediatrics, published online Sept. 15.

Liraglutide 3 mg (Saxenda, Novo Nordisk) has been recommended by an FDA Advisory Committee to be approved for use in the treatment of obesity

FDA has approved a new treatment option for opioid-induced constipation in adult patients with chronic noncancer pain. Naloxegol (Movantik, AstraZeneca) tablets C-II is the first once-daily, oral, peripherally acting µ-opioid receptor antagonist (PAMORA) to be approved for this condition.

About 1,000 cases of the respiratory illness caused by Enterovirus D68 have been confirmed in 10 states in the United States so far. Many of these children are being hospitalized for it.

FDA has approved a combination of the generic drugs naltrexone and bupropion (Contrave) for chronic weight management in obese adults (body mass index [BMI] >30 kg/m2). This combination agent has also been approved for use in those patients who are overweight (BMI >27 kg/m2) and have at least one weight-related comorbid condition such as diabetes, hypertension, or dyslipidemia.

Medication-related problems (MRPs) can be a significant patient safety risk, particularly in hospitalized patients. One method used to minimize this safety concern is through medication reconciliation, or the process of documentation of a patient’s outpatient medication list at the time of hospital admission. Medication reconciliation can be performed by any trained health care professional (i.e. nurses, pharmacy technicians, physicians, etc.), however improved patient safety outcomes have been demonstrated when pharmacists perform this process.

In 1983, the United States enacted the Orphan Drug Act (ODA). An analogous law was passed in Europe in 2000. Both pieces of legislation are considered major successes in terms of spurring the development of orphan drugs. To illustrate, in the decade prior to 1983 only 34 orphan products were marketed, whereas in the past year alone 9 orphan drugs were launched. In the past 5 years, 39 orphan drugs were launched in the US across numerous therapeutic categories, including multiple myeloma, chronic myeloid leukemia, metastatic non-small cell lung cancer, hemophilia, tuberculosis, homozygous familial hypercholesterolemia, and cystic fibrosis.1